Recruitment

Recruitment Status
Completed
Estimated Enrollment
250

Inclusion Criterias

eGFR are in a range of 15 - 59 ml/min/1.73m2 estimated twice at 3 months.
ages 18-70 years and known to have diabetes and/or hypertension.
eGFR are in a range of 15 - 59 ml/min/1.73m2 estimated twice at 3 months.
ages 18-70 years and known to have diabetes and/or hypertension.

Exclusion Criterias

unstable/advanced cardiovascular disease
active glomerular disease, obstructive uropathy, end-stage renal disease, HIV infection, pregnancy, body mass index (BMI) less than 18 or more than 40 kg/m2, being under treatment for malignancy, urine protein-creatinine ratio more than 3.5 g/g creatinine and active urinary sediment (urine red blood cells >3 cells/high power field or urine white blood cells >10 cells/high power field).
unstable/advanced cardiovascular disease
active glomerular disease, obstructive uropathy, end-stage renal disease, HIV infection, pregnancy, body mass index (BMI) less than 18 or more than 40 kg/m2, being under treatment for malignancy, urine protein-creatinine ratio more than 3.5 g/g creatinine and active urinary sediment (urine red blood cells >3 cells/high power field or urine white blood cells >10 cells/high power field).

Summary

Conditions
Chronic Kidney Disease
Type
Interventional
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 70 years
Gender
Both males and females

Description

Background The unique characteristic of community-health care in Thailand is a system of primary- health care officers and Village Health Volunteers (VHVs) providing basic health care to more than 90% of Thai population. Should these allied personnel be trained on how to render proper chronic kidney...

Background The unique characteristic of community-health care in Thailand is a system of primary- health care officers and Village Health Volunteers (VHVs) providing basic health care to more than 90% of Thai population. Should these allied personnel be trained on how to render proper chronic kidney disease (CKD) care, it would be interesting to study whether their role play care will result in better quality of CKD care. Design This study is a community-based cluster randomized controlled trial to be conducted in 2 districts of Kamphaeng Phet Province, located about 400 kilometers north of Bangkok. About 300 stage 3-4 CKD patients will be enrolled to each of the 2 treatment groups. Patients in both groups will be treated according to The National Kidney Foundation Kidney Disease Outcomes Quality Initiative guidelines. The District 1 (control group) patients will be provided a conventional CKD care. For the District 2 (intervention group) patients, an integrated CKD care program will be provided by the multidisciplinary team of district hospital in conjunction with the community CKD care networks (i.e. primary-health care officers and VHVs). The key activities of integrated CKD care program are live demonstration about treatment and optimal diets for CKD patients which will be provided during each hospital visit and quarterly home visits. Clinical and laboratory parameters of all cases will be assessed every 3 months. Duration of the study is 24 months. The primary outcome of this study is the rate of eGFR decline. The secondary outcomes are time of initiation of dialysis, cardiovascular mortality, and all-cause mortality.

Inclusion Criterias

eGFR are in a range of 15 - 59 ml/min/1.73m2 estimated twice at 3 months.
ages 18-70 years and known to have diabetes and/or hypertension.
eGFR are in a range of 15 - 59 ml/min/1.73m2 estimated twice at 3 months.
ages 18-70 years and known to have diabetes and/or hypertension.

Exclusion Criterias

unstable/advanced cardiovascular disease
active glomerular disease, obstructive uropathy, end-stage renal disease, HIV infection, pregnancy, body mass index (BMI) less than 18 or more than 40 kg/m2, being under treatment for malignancy, urine protein-creatinine ratio more than 3.5 g/g creatinine and active urinary sediment (urine red blood cells >3 cells/high power field or urine white blood cells >10 cells/high power field).
unstable/advanced cardiovascular disease
active glomerular disease, obstructive uropathy, end-stage renal disease, HIV infection, pregnancy, body mass index (BMI) less than 18 or more than 40 kg/m2, being under treatment for malignancy, urine protein-creatinine ratio more than 3.5 g/g creatinine and active urinary sediment (urine red blood cells >3 cells/high power field or urine white blood cells >10 cells/high power field).

Locations

Bangkok, 10400
Bangkok, 10400

Tracking Information

NCT #
NCT01978951
Collaborators
Ministry of Health, Thailand
Investigators
  • Principal Investigator: Teerayuth Jiamjariyaporn, M.D. Bhumirajanagarindra Kidney Institute
  • Teerayuth Jiamjariyaporn, M.D. Bhumirajanagarindra Kidney Institute